- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04926207
The Effects of Interrupting Prolonged Sitting With Bouts of Physical Activity on Neurocognitive Function in Obesity (SITLess)
February 5, 2024 updated by: University of Illinois at Urbana-Champaign
SIT Less! Interrupting Prolonged Sitting With Brief Physical Activity Bouts to Improve Neurocognitive Function in Adults With Obesity
It is projected that by 2030 almost 50% of adults in the USA will have obesity.
High sedentariness and physical inactivity contribute to the obesity pandemic.
Neurocognitive deficits compound the global burden of obesity.
Specifically, adults with obesity underperform on tasks of executive functioning, which underpin goal-directed behavior and have been linked to occupational success.
Growing evidence suggests poorer executive functioning among more sedentary adults.
Emergent studies have shown that accumulating sedentary time in prolonged bouts (e.g., remaining sedentary continuously 20 min or more) may decrease the ability to control distractions along with working memory.
Interrupting prolonged sitting with brief bouts of physical activity is an effective strategy to improve postprandial glucose metabolism.
However, the effects of this simple intervention on neural processes supporting executive functioning remain unknown.
Accordingly, the aim of this study is to test the effects of interrupting prolonged sitting with frequent (every 30 min) but brief (3 min) physical activity bouts on inhibitory control, working memory, and their neuroelectric indices (N2, P3a, and P3b components of event-related brain potentials).
Our secondary aim is to explore the potential mechanisms underlying the effects of interrupting prolonged sitting with physical activity on cognitive and brain function through glucose metabolism and insulin physiology.
Findings from this study will help advance our understanding of how restructuring sedentary time may help improve cognitive and brain functions among adults with obesity.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Measurements of cognitive and brain function will be taken before, and after three hours of prolonged sitting.
Metabolic, heart rate, and blood pressure measures, along with the ratings of fatigue will be collected before and during the three-hour prolonged sitting time.
The prolonged sitting time will be either interrupted with physical activity breaks or with sedentary breaks (attention control).
Habitual physical activity, sedentary behavior, sleep, and dietary intake will also be assessed.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Urbana, Illinois, United States, 61801
- University of Illinois at Urbana-Champaign
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
• Informed consent
- Age 21-64 years
- BMI within ≥ 30 and < 40 kg/m2 range
- Pre-menopausal
- Fasting plasma glucose (FPG) < 100 mg/dL
- Resting blood pressure: systolic < 160 mmHg or diastolic < 100 mmHg
- Employed in sedentary occupation (i.e., participants reporting sitting on average 6 h/d on a weekday and with objectively assessed sitting time ≥ 8 h/day)
- Physically inactive (i.e., engaging in < 150 min of moderate or < 75 min of vigorous or any combination of the two intensities per week)
- Participants must have had no prior diagnosis of cognitive or physical disability (e.g., ADHD, severe asthma, epilepsy, chronic kidney disease, or dependence upon a wheelchair/walking aid)
- Free of medication that could affect cognitive function or metabolism
- Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision)
- Must be able to engage in vigorous exercise
- Fluency in English
Exclusion Criteria:
• Impaired glucose tolerance defined as fasting plasma glucose (FPG) < 100 mg/dL
- Oral glucose tolerance test (OGTT) blood glucose values ≥ 200 mg/dL
- Participants with any psychiatric, neurological or metabolic disorder
- Participants who have or are currently taking the medication that could affect cognitive function, metabolism or weight status
- Participants with substance abuse
- Participants with a standardized score on the test of general cognitive abilities below 85
- Participants with anemia
- Pregnant women or those with a possible pregnancy
- History of injury to the spinal cord
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physical Activity Breaks Intervention
Participants will sit continuously for 3 hours and interrupt their sitting by walking on a treadmill at a moderate intensity for 3 min.
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Participants will be asked to walk on a treadmill for 3 min at a moderate intensity (55% of heart rate reserve) at an increasing speed and incline to reach and maintain their target heart rate.
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Active Comparator: Talking Breaks Control
Participants will sit continuously for 3 hours.
They will interrupt solitary sitting activities (while remaining seated) by talking to a researcher for 3 min on pre-selected topics of general interest.
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Every 30 min a researcher will start a brief conversation with a participant based on a pre-selected topic, which will change with each break.
Topics are standardized across participants and include, for example, pollution, smart clothes, and hydration.
A presentation will be followed by questions and answers.
The break will last 3 min.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuroelectric measures of inhibitory control - P3 component of event-related potentials (ERPs)
Time Frame: Assessed immediately before and after the intervention (on the same day as intervention)
|
The change in the P3 component measured during the modified flanker task
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Assessed immediately before and after the intervention (on the same day as intervention)
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Neuroelectric measures of inhibitory control - N2 component of event-related potentials (ERPs)
Time Frame: Assessed immediately before and after the intervention (on the same day as intervention)
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The change in the N2-ERP component measured during the modified flanker task.
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Assessed immediately before and after the intervention (on the same day as intervention)
|
|
Inhibitory control measured with a modified flanker task - accuracy
Time Frame: Assessed immediately before and after the intervention (on the same day as intervention)
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The change in accuracy on the modified flanker task
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Assessed immediately before and after the intervention (on the same day as intervention)
|
|
Inhibitory control measured with a modified flanker task - reaction time
Time Frame: Assessed immediately before and after the intervention (on the same day as intervention)
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The change in measures of reaction time on the modified flanker task
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Assessed immediately before and after the intervention (on the same day as intervention)
|
|
Neuroelectric measures of working memory - P3-ERP component
Time Frame: Assessed immediately before and after the intervention (on the same day as intervention)
|
The change in the P3-ERP component during the n-back task.
|
Assessed immediately before and after the intervention (on the same day as intervention)
|
|
Working memory measured with an n-back task - accuracy
Time Frame: Assessed immediately before and after the intervention (on the same day as intervention)
|
The change in accuracy on the n-back task
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Assessed immediately before and after the intervention (on the same day as intervention)
|
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Working memory measured with an n-back task - reaction time
Time Frame: Assessed immediately before and after the intervention (on the same day as intervention)
|
The change in measures of reaction time on the n-back task
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Assessed immediately before and after the intervention (on the same day as intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-prandial insulin response during an oral glucose tolerance test
Time Frame: Assessed during the intervention
|
Insulin Area Under the Curve (AUC)
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Assessed during the intervention
|
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Post-prandial glucose response during an oral glucose tolerance test
Time Frame: Assessed during the intervention
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Glucose Area Under the Curve (AUC)
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Assessed during the intervention
|
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Matsuda index
Time Frame: Assessed during the intervention
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Insulin Sensitivity measured with Matsuda index
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Assessed during the intervention
|
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Stumvoll metabolic clearance rate (MCR)
Time Frame: Assessed during the intervention
|
Insulin Sensitivity expressed as Stumvoll metabolic clearance rate
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Assessed during the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dominika M Pindus, PhD, University of Illinois at Urbana-Champaign
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 3, 2021
Primary Completion (Estimated)
May 31, 2024
Study Completion (Estimated)
May 31, 2024
Study Registration Dates
First Submitted
May 24, 2021
First Submitted That Met QC Criteria
June 6, 2021
First Posted (Actual)
June 15, 2021
Study Record Updates
Last Update Posted (Actual)
February 7, 2024
Last Update Submitted That Met QC Criteria
February 5, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20633
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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